Colorado-Oregon Altitude Study

NCT05734716 | Completed Phase 4 FDA Drug

• 1 other identifier: STUDY00000019
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

Brief Summary

Investigating the utility of prophylactic treatment with iron sucrose and/or erythropoietin on the prevention of acute mountain sickness in fit, young, healthy individuals.

Conditions

Acute Mountain Sickness

Outcome Measures

Primary Outcomes (30)

• Lake Louise Score

  Lake Louise Score of Acute Mountain Sickness symptoms

  Pre-ascension to altitude

• Lake Louise Score

  Lake Louise Score of Acute Mountain Sickness symptoms

  Day 1 ascent to altitude

• Lake Louise Score

  Lake Louise Score of Acute Mountain Sickness symptoms

  24 hours after ascent to altitude

• Hemoglobin Mass

  total mass of hemoglobin in body

  Pre-ascent to altitude

• Hemoglobin Mass

  total mass of hemoglobin in body

  Day 1 of Altitude

• Hemoglobin Mass

  total mass of hemoglobin in body

  Day 7 of Altitude

• Hemoglobin Mass

  total mass of hemoglobin in body

  Day 13 of Altitude

• five kilometer run time trial

  time to cover 5 kilometers

  Pre-ascension to altitude

• five kilometer run time trial

  time to cover 5 kilometers

  Day 1 of Altitude

• five kilometer run time trial

  time to cover 5 kilometers

  Day 7 of Altitude

• five kilometer run time trial

  time to cover 5 kilometers

  Day 13 of Altitude

• p50

  oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen

  Pre-ascension to altitude

• p50

  oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen

  Day 1 of Altitude

• p50

  oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen

  Day 7 of Altitude

• p50

  oxygen partial pressure point at which hemoglobin is 50% saturated with oxygen

  Day 13 of Altitude

• rucksack carry

  time to complete rucksack (35 pounds) course

  Pre-ascent to altitude

• rucksack carry

  time to complete rucksack (35 pounds) course

  Day 2 of altitude

• rucksack carry

  time to complete rucksack (35 pounds) course

  Day 14 of altitude

• pulmonary arterial systolic pressure

  highest pressure experienced in pulmonary vasculature during cardiac cycle

  Pre-ascent to altitude

• pulmonary arterial systolic pressure

  highest pressure experienced in pulmonary vasculature during cardiac cycle

  day 1 ascent to altitude

• pulmonary arterial systolic pressure

  highest pressure experienced in pulmonary vasculature during cardiac cycle

  day 7 ascent to altitude

• pulmonary arterial systolic pressure

  highest pressure experienced in pulmonary vasculature during cardiac cycle

  day 13 ascent to altitude

• hypercapnic ventilatory response

  level of end-tidal carbon dioxide which stimulates a ventilatory response

  Pre-ascent to altitude

• hypercapnic ventilatory response

  level of end-tidal carbon dioxide which stimulates a ventilatory response

  Day 1 of Altitude

• hypercapnic ventilatory response

  level of end-tidal carbon dioxide which stimulates a ventilatory response

  Day 7 of Altitude

• hypercapnic ventilatory response

  level of end-tidal carbon dioxide which stimulates a ventilatory response

  Day 13 of Altitude

• body core temperature

  body core temperature as measured by telemetric pill

  during 5k time trial pre-ascent to altitude

• body core temperature

  body core temperature as measured by telemetric pill

  during 5k time trial day 1 of Altitude

• body core temperature

  body core temperature as measured by telemetric pill

  during 5k time trial day 7 of Altitude

• body core temperature

  body core temperature as measured by telemetric pill

  during 5k time trial day 13 of Altitude

Study Arms (3)

EPO Arm

EXPERIMENTAL

participants administered subcutaneous erythropoietin injection (50 IU/kg 3x/week for 3 weeks) prior to ascent to altitutude. participants additionally administered sham intravenous treatment twice, with dosages occurring three weeks apart and final shame dose occurring 48 hours prior to ascent to altitude.

Drug: Erythropoietin

Iron Arm

EXPERIMENTAL

participants administered intravenous iron sucrose (200mg) twice, dosages occurring three weeks apart with final dosing occurring 48 hours prior to ascent to altitude. Participants additionally administered sham subcutaneous injection (sterile saline) 3x/week for 3 weeks.

Drug: Iron sucrose (Venofer)

Placebo

PLACEBO COMPARATOR

participants administered sham injections (sterile saline) 3x/week for 3 weeks as well as sham intravenous infusion (sterile saline) twice with dosages occurring three weeks apart and final dosing occurring 48 hours prior to ascent to altitude.

Drug: Sterile Sodium Chloride

Interventions

Erythropoietin DRUG

use of erythropoietin to stimulate red blood cell development prior to ascent to altitude

EPO Arm

Iron sucrose (Venofer) DRUG

use of iron sucrose to stimulate red blood cell development prior to ascent to altitude

Iron Arm

Sterile Sodium Chloride DRUG

sham treatment with sterile saline

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18 to 40
• Recreational athletes able to pass the APFTs
• Men and women of any ethnic background
• Medical and dental insurance
• Able to read and speak English
• Fully vaccinated against COVID-19
• If a subject is taking medication that is deemed safe and will not interfere with the main outcome measurements of the study as determined by clinical research staff, they will be included.
• If a subject had a previous mild to moderate COVID-19 infection but is deemed safe for all research activities by clinical research staff, then they will be included in the study.

You may not qualify if:

• Smokers
• Carboxyhemoglobin values (HbCO) 3% or greater at baseline
• Diseases or disorders known to be affected by hypoxia or the drugs used in this study, including but not limited to hypotension, anemia, sickle cell trait or disease, and diabetes.
• Anyone unable to receive the investigational drugs used in this protocol (EPO or iron).
• Those with a history of significant head injury, migraines or seizures.
• Anyone that is pregnant or trying to become pregnant.
• Any medication determined by the clinical research staff to be unsafe or to interfere with the outcome measurements of the study.
• Those with inability to be headache-free when consuming the amount of caffeine in two six-ounce cups of coffee or less per day.
• Extended exposure (\>6 hours) to high altitude above 1000m in the month leading up to departure to Colorado.
• Those who have been on an airline flight over six hours (the lowered cabin pressure for an extended period of time approximates exposure to high altitude) within the month leading up to departure to Colorado.
• Those who are unable to achieve the minimum physical criteria as outlined above.
• Anyone with lung function below the lower limit of normal per GLI standards.
• Previous diagnosis of high altitude pulmonary edema or high altitude cerebral edema upon altitude exposure.
• Family history of clotting disorders, anemia or venous thrombosis.
• Plans for professional competition during or within 1 week after participation in this study as participation may enhance your aerobic performance

Sponsors & Collaborators

• University of Oregon: lead

Study Sites (2)

Colorado Mountain College

Leadville, Colorado, 80461, United States

Location

Cardiopulmonary and Respiratory Physiology Lab

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Altitude Sickness

Interventions

Erythropoietin; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants and researchers involved in data collection are blinded to the treatment assignment of all participants.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 21, 2023
• Study Start: February 17, 2021
• Primary Completion: August 1, 2022
• Study Completion: January 1, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)